Inside Washington: GMP Progress Report

Wechsler,Jill;

Publication

Article

April 15, 2003

BioPharm International

BioPharm International-04-01-2003

Volume16

Issue 4

Inside Washington: GMP Progress Report

Author(s):

Jill Wechsler

by Jill Wechsler, BioPharm International Six months into its initiative to update manufacturing regulations, FDA announces a raft of changes covering warning letters, inspections, and comparability ? plus a fresh start on Part 11.

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Articles in this issue

Virus Inactivation in the 1990s and into the 21st Century

Using Peptide Maps as Identity and Purity Tests for Lot Release Testing of Recombinant Therapeutic Proteins

Getting Ready for Risk-Based GMPs

GMP Issues: Breaking Ground

Guest Editorial: Benchmarking Biotech

Optimized Nutrient Additives for Fed-Batch Cultures

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